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Clinical Trial 20827

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04032847

Phase: Phase I
Principal Investigator: Creelan, Benjamin

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or 1-800-679-0775 Learn More

Overview

Study Title

An Open-Label, Multi-Center Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)

Summary

This is a first-in-human, open-label, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).

Objective

Primary Objective: -To assess the safety and tolerability of ATL001 therapy. Secondary Objective: -To evaluate the clinical efficacy of ATL001 using RECIST v1.1 and imRECIST. Exploratory Objectives: -To evaluate the persistence, phenotype and functionality of NAR-T cells and to explore possible relationships with clinical outcomes. -To evaluate potential biomarkers of clinical activity and factors affecting response. -To evaluate manufacturing rate and factors that may affect the quality of ATL001. -To evaluate the utility of a bespoke plasma ctDNA assay. -To evaluate pleural fluid as a source of T cells and free tumor DNA.

Treatments

Therapies

Cell Therapy; Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

ATL001 (); IL-2 (Interleukin-2); Pembrolizumab (Keytruda); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

Patient must be at least 18 years old

Patient must have given written informed consent

Confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related

ECOG Performance status 0-1

Anticipated life expectancy > 6 months

Measurable disease according to RECIST 1.1 criteria

Adequate organ function

Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures

Patient is considered, in the opinion of the investigator, capable of adhering to the protocol.

If female, patient must be either postmenopausal, sterilised or, if sexually active, effectively practicing a highly effective method of contraception.

Male patients agree to ensure that they or their female partner(s) use a highly effective method of contraception during the study

Exclusion Criteria

Patients with known central nervous system metastases that are untreated or symptomatic or progressing.

Patients with active infectious disease

Patients who are non-smokers

Patients requiring immunosuppressive treatments.

Patients requiring regular treatment with systemic steroids

Patients with superior vena cava syndrome

Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease

Patients who are pregnant or breastfeeding

Patients who have undergone major surgery in the previous 3 weeks

Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas or non-melanomatous skin cancers)

Patients with a history of organ transplantation.

Patients who have received any investigational cell or gene therapies

Patients with contraindications for protocol specified agents

Patients with a history of immune mediated central nervous system toxicity with causal or suspected causal link to immunotherapy

Patients with a history of Grade 2 or greater diarrhea/colitis caused by previous immunotherapy within 6 months of screening. Patients that have been asymptomatic for at least 6 months or have had a normal colonoscopy post-immunotherapy (with uninflamed mucosa by visual assessment following discontinuation of immune suppression other than permitted modified release steroids) are not excluded.

Patients wuth confirmed history of allergic reactions to amphotericin b, penicillin and/or streptomycin

Additional exclusion criteria may apply to define procedures within the protocol

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